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FDA 510(k) Application Details - K222199
Device Classification Name
More FDA Info for this Device
510(K) Number
K222199
Device Name
Collagen P.I.N. (Percutaneous Induction Needling)
Applicant
Induction Therapies LLC
1920 Stanley Gault Parkway, Suite 100
Louisville, KY 40223 US
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Contact
Amelia Aslam
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QAI
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More FDA Info for this Product Code
Date Received
07/22/2022
Decision Date
10/21/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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